check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

11139

ClinicalTrials.gov Identifier:

NCT00661596

EudraCT Number:

Not Available

EU CT Number:

Not Available
Assessment of efficacy of vardenafil, influence on self-esteem and self-confidence in subjects with erectile dysfunction

Trial purpose

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Age: 18 years and older
    - Males with erectile dysfunction
    - Stable heterosexual relationship

  • - Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
    - Nitrate use
    - Other exclusion criteria apply acc. to Summary of Product Characteristics

Trial summary

Enrollment Goal
129
Trial Dates
May 2003 - January 2004
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Málaga, 29010, Spain
Completed
Valladolid, 47011, Spain
Completed
Móstoles, 28935, Spain
Completed
Alicante, 03010, Spain
Completed
Oviedo, 33006, Spain
Completed
Barcelona, 08025, Spain
Completed
Sevilla, 41071, Spain
Completed
Valencia, 46014, Spain
Completed
Sabadell, 08208, Spain
Completed
Vigo, 36211, Spain
Completed
Hondarribia, 28280, Spain
Withdrawn
Leganés, 28911, Spain
Completed
Granada, 18003, Spain

Primary Outcome

  • International Index of Erectile Function - Erectile Function Domain
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Global Assessment Questionnaire
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • IIEF-EF domain score
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Other diary based variables
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety and tolerability
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

Multi-centre, randomised, double-blind, parallel, placebo-controlled clinical study to assess the efficacy of vardenafil and its influence on self-esteem and self-confidence in patients with erectile dysfunction
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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